The Clinical Data Manager develops and implements data-oriented systems to meet the needs of the organization. Duties include developing systems, procedures, and policies for data management for the Clinical Trials team and assisting colleagues in performing data-related tasks.
Primary Responsibilities
- Contributes to data management activities including eCRF development by leading cross-functional reviews of eCRF content.
- Establishes Database building activities, including review of edit check specifications and performance of user acceptance testing.
- Monitors data collection, remote and source data verification (SDV), coding, and cleaning by vendors through tracking of study metrics and targeted data reviews
- Oversees of database lock activities and ultimate archiving of study data
- Collaborates with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Product Safety; CROs, central and local laboratories, and other vendors.
- Establishes cross-functional, internal data review plans, coordinate data cuts/transfers, and conduct data reviews.
- Reviews CRO data management plans, CRF completion guidelines, edit check specifications, external data transfer specifications and other study documentation.
- Represents data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors.
- Participates in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met.
- Reviews clinical protocols/amendments, clinical study reports, statistical analysis plans, etc.
- Supports GCP inspection readiness
Requirements
- BS/BA in scientific discipline, MS or equivalent preferred, with at least 3 years related experience in a medical device/diagnostic/software/pharmaceuticals/biologics/biotechnology company
- Experience with global studies, utilizing an outsourced CRO model.
- Experience in clinical MedTech and drug development through concept to post-approval
- Education or work experience in a health-related field
- Expert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems
- Knowledge and understanding of regulations and industry-adopted data standards, such as CDISC SDTM and CDASH
- Experience working with multiple EDC platforms.
- Experience using standardized medical terminology, including MedDRA and WHODrug
- Experience working with MS Office Suite (Excel, Word, and PowerPoint) and familiarity with MS Project
- Excellent written and oral communication skills
- Highly motivated and flexible, with excellent organizational and time management skills
- Ability to work independently and as part of a multi-disciplinary team
- Understanding of ICH GCP as well as general knowledge of industry practices and standards
- Knowledge and understanding of regulatory requirements and expectations for clinical data systems including 21 CFR Part 11 and applicable ISO and CFR regulations.
Behaviors
- Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning
Being an industry leader in regulatory and quality consulting is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!
We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.
